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510(k) K250834

Zimmer Biomet Ceramic Heads (22.2mm diameter) by Zimmer Biomet — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2025
Date Received
March 19, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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